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Post by mnholdem on Jan 7, 2018 10:03:06 GMT -5
This article is about a new report (for which you must pay, of course). Normally, I wouldn't post such links but there is a paragraph or two by the author that, IMHO, really captures the challenge facing MannKind among KOLs.
JANUARY 6, 2018 BY MARCIN KAPUŚCIŃSKI
Diabetes – KOL Insight and Consensus Outlook Modules
Excerpt:
What the Future Holds: is there a Game Changer on the Horizon?
Don't expect a revolution in diabetes treatment soon. New products coming to market are essentially incremental improvements over current approaches, with better safety profiles and geared to improving patient compliance.
The real prize will be for the company that can bring a paradigm shift to the treatment of diabetes. Upsetting the status quo will require a fundamentally different approach – and some of these developments threaten the diabetes drugs manufacturers existing revenues.
Among the developments to be aware of are the threat of biosimilars, the development of an artificial pancreas 'closed loop' system, the wide implementation of which would be a doomsday development for drugs companies, and a DNA reverse vaccine for which early clinical results have shown promise.
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In my opinion, the statement I quoted (above) reflects the true challenge facing MannKind and CEO Mike Castagna. Key Opinion Leaders (KOL) don't see Afrezza as "a shift to the treatment of diabetes" and the perception that Afrezza is just another insulin is the true challenge that Mike must address to win the "real prize".
I am firmly of the belief that a major study could be conducted and, based on over ten years of meta-data collected from similar trials, would prove that early short-term intensive insulin (STII) therapy as the first treatment for early stage diabetes mellitus would result a complete remission of the disease. Recent beta-analysis reports have concluded that nearly 50% of STII therapy patients achieved drug-free remission of diabetes for up to two years. One team also published their opinion that it is resistance to having to administer needle injections that is largely responsible for STII therapy not being adopted as a first line of therapy.
This is where MannKind could step in. STII therapy using Afrezza could become the paradigm change that the author speaks of. Considering that diabetes has reached epidemic proportions, I would think that even the Gates Foundation would consider funding the study.
I've often considered approaching friends at the Mayo Clinic with this concept.
It's Outside-the-Box thinking, but I think the idea of conducting an Afrezza STII study has merit. Perhaps there are others in the medical research industry who will think the same thing.
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Post by mnholdem on Jan 7, 2018 10:15:31 GMT -5
The current study being conducted by Model Clinical Research LLC comes close, since it introduces Afrezza therapy after 6 months of failed initial OAD treatment. I hope that Dr. Levin proves Alfred Mann's remarks that first line treatment with Afrezza will result in remission of early diabetes. Many STII studies would indicate that this is likely and it just might be the fruit of Levin's research. clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza+inhaled&rank=2Also results from the Yale University study could prove to be game changing, since it uses Afrezza with closed-loop therapy, which is one of the paradigm shifting treatments that the author listed as having the potential to decimate the revenues of the current major diabetes drug companies. clinicaltrials.gov/ct2/show/NCT03234491?term=Afrezza+inhaled&rank=4--- The fact that MannKind has chosen to sponsor these trials bolsters my confidence that management and the Board of Directors are working toward changing KOL perceptions of Afrezza and are looking at collaborating with potential game-changing treatments like closed-loop therapy and advances in self-directed patient blood monitoring technologies. |
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Post by centralcoastinvestor on Jan 7, 2018 10:48:16 GMT -5
I have often seen Mike C. quoted as saying that people need to see the bigger picture. Having read or watched most of what Mike C. has participated in whether it be interviews or quarterly meetings, Mike C. appears to be a smart and passionate CEO. I believe he has very big ideas for Afrezza and Technosphere. However, he knows it takes time to achieve big picture goals. It is hard to please shareholders who are looking at weekly script counts when some of the goals are possibly multi year efforts. Mike has only been in charge for roughly a year (I hope I have that right). That’s not a lot of time to pull off a big picture plan. Mike has to balance shareholder and Wallstreet short term expectations with achieving major big picture goals. It isn’t easy.
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Post by digger on Jan 7, 2018 11:06:03 GMT -5
Just a casual google search indicates a great deal of excitement about the up and coming "artificial pancreas" systems. Patients are even having to get on a wait list in order to get one of the Medtronics' 670G pumps.
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Post by digger on Jan 7, 2018 11:08:57 GMT -5
The current study being conducted by Model Clinical Research LLC comes close, since it introduces Afrezza therapy after 6 months of failed initial OAD treatment. I hope that Dr. Levin proves Alfred Mann's remarks that first line treatment with Afrezza will result in remission of early diabetes. Many STII studies would indicate that this is likely and it just might be the fruit of Levin's research. clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza+inhaled&rank=2Also results from the Yale University study could prove to be game changing, since it uses Afrezza with closed-loop therapy, which is one of the paradigm shifting treatments that the author listed as having the potential to decimate the revenues of the current major diabetes drug companies. clinicaltrials.gov/ct2/show/NCT03234491?term=Afrezza+inhaled&rank=4--- The fact that MannKind has chosen to sponsor these trials bolsters my confidence that management and the Board of Directors are working toward changing KOL perceptions of Afrezza and are looking at collaborating with potential game-changing treatments like closed-loop therapy and advances in self-directed patient blood monitoring technologies. The second one says it was posted last July, but still shows it isn't yet recruiting. Why? Also, it says it's going to take almost 4 years to study just 25 patients. That seems a bit extreme to me. |
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Post by mnholdem on Jan 7, 2018 11:20:04 GMT -5
It's up to the sponsor to update status at ClinicalTrials. It's not at all uncommon for sponsors to neglect update trial status in a timely manner. When a company is the sponsor, the trial status tends to get updated more frequently, especially if it's a publicly held company, to keep shareholders informed. Unfortunately, most universities don't care about shareholder concerns.
Regarding the the duration of this study:
The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.
This is to be a very detailed study with both low-dose and high-dose arms, the safety of which will be determined in a clinical setting (Phase I) and will probably involve a great deal of calibrating - there is also the Closed-Loop device to consider - and adjusting treatment protocols prior to moving the trial into an outpatient setting (Phase II).
The duration of this trial indicates, to me, the this is a major trial that could have significant impact on the industry. Yale University has published many studies in Lancet and superior results would be phenomenal for Afrezza. It may be tough to wait so long to learn the results but the eventual publication may be a pivotal event for MannKind and its shareholders.
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Post by digger on Jan 7, 2018 11:50:56 GMT -5
It's up to the sponsor to update status at ClinicalTrials. It's not at all uncommon for sponsors to neglect update trial status in a timely manner. When a company is the sponsor, the trial status tends to get updated more frequently, especially if it's a publicly held company, to keep shareholders informed. Unfortunately, most universities don't care about shareholder concerns. Regarding the the duration of this study: The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.This is to be a very detailed study with both low-dose and high-dose arms, the safety of which will be determined in a clinical setting (Phase I) and will probably involve a great deal of calibrating - there is also the Closed-Loop device to consider - and adjusting treatment protocols prior to moving the trial into an outpatient setting (Phase II). The duration of this trial indicates, to me, the this is a major trial that could have significant impact on the industry. Yale University has published many studies in Lancet and superior results would be phenomenal for Afrezza. It may be tough to wait so long to learn the results but the eventual publication may be a pivotal event for MannKind and its shareholders. It may be detailed but with only 25 subjects, I don't think it quite qualifies as major. |
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Post by mango on Jan 7, 2018 15:24:22 GMT -5
It's up to the sponsor to update status at ClinicalTrials. It's not at all uncommon for sponsors to neglect update trial status in a timely manner. When a company is the sponsor, the trial status tends to get updated more frequently, especially if it's a publicly held company, to keep shareholders informed. Unfortunately, most universities don't care about shareholder concerns. Regarding the the duration of this study: The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.This is to be a very detailed study with both low-dose and high-dose arms, the safety of which will be determined in a clinical setting (Phase I) and will probably involve a great deal of calibrating - there is also the Closed-Loop device to consider - and adjusting treatment protocols prior to moving the trial into an outpatient setting (Phase II). The duration of this trial indicates, to me, the this is a major trial that could have significant impact on the industry. Yale University has published many studies in Lancet and superior results would be phenomenal for Afrezza. It may be tough to wait so long to learn the results but the eventual publication may be a pivotal event for MannKind and its shareholders. Agree with everything you've said in this thread. Afrezza was chosen to be used with the closed-loop artificial pancreas for a reason and we already know what that is. The clinical trial is a majorly significant one. This is THE trial. The wait will be worth it for everyone. |
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Post by babaoriley on Jan 7, 2018 16:49:42 GMT -5
Are those here that know something about such trials confident that a 25 person trial will be sufficient to have endos and pcps take note of the hopefully positive conclusions of this trial?
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Post by joeypotsandpans on Jan 7, 2018 17:04:36 GMT -5
I met with my new endo friday, they took my Libre and downloaded the data and printed out the graphs etc. This particular endo has been working with Afrezza since its inception with Sanofi. You can tell he has experience with it as he is starting me out on a specific regimen with an initial dose with each meal and then if above target range after 2 hrs. a supplemental correction dose. The previous endo I recently went to if you recall I was her first patient she was seeing on Afrezza as they were part of the OPTUM network (UHC) and although she was enthusiastic now that my coverage has changed for the better I went with the one experienced and has worked with the local reps (both prior rep that was with SNY and now with DEXCOM and the current rep that was with DEXCOM and now with MNKD) The reason I bring this up on this particular thread is because at the end of my visit I asked, so overall what are your thoughts about Afrezza? He used the specific term in the title of this thread, his response was very direct....."GAME CHANGER!!"  ...he did add the biggest issue was coverage but he had the Afrezza posters both in the waiting rooms and in the room I was attended to so it showed his commitment and advocacy of the product. BTW, his waiting room was at full capacity. He is pretty high on the DEXCOM, I was his first patient that was using the Libre, he has seen many with the freestyle Pro over the last few mos. He asked why I chose the Libre over the DEXCOM since I knew the DEXCOM rep formerly from SNY....I said primarily the cost difference and then joked...well she bailed on Afrezza to which he correctly replied no SNY bailed on her  |
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Post by sayhey24 on Jan 7, 2018 19:40:49 GMT -5
I met with my new endo friday, they took my Libre and downloaded the data and printed out the graphs etc. This particular endo has been working with Afrezza since its inception with Sanofi. You can tell he has experience with it as he is starting me out on a specific regimen with an initial dose with each meal and then if above target range after 2 hrs. a supplemental correction dose. The previous endo I recently went to if you recall I was her first patient she was seeing on Afrezza as they were part of the OPTUM network (UHC) and although she was enthusiastic now that my coverage has changed for the better I went with the one experienced and has worked with the local reps (both prior rep that was with SNY and now with DEXCOM and the current rep that was with DEXCOM and now with MNKD) The reason I bring this up on this particular thread is because at the end of my visit I asked, so overall what are your thoughts about Afrezza? He used the specific term in the title of this thread, his response was very direct....."GAME CHANGER!!" ...he did add the biggest issue was coverage but he had the Afrezza posters both in the waiting rooms and in the room I was attended to so it showed his commitment and advocacy of the product. BTW, his waiting room was at full capacity. He is pretty high on the DEXCOM, I was his first patient that was using the Libre, he has seen many with the freestyle Pro over the last few mos. He asked why I chose the Libre over the DEXCOM since I knew the DEXCOM rep formerly from SNY....I said primarily the cost difference and then joked...well she bailed on Afrezza to which he correctly replied no SNY bailed on her Did your graphs demonstrate afrezza really is the GAME CHANGER? If you had the time and your old doc had the time it would be interesting to explain the protocol and share your results. |
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Post by joeypotsandpans on Jan 8, 2018 14:26:55 GMT -5
I met with my new endo friday, they took my Libre and downloaded the data and printed out the graphs etc. This particular endo has been working with Afrezza since its inception with Sanofi. You can tell he has experience with it as he is starting me out on a specific regimen with an initial dose with each meal and then if above target range after 2 hrs. a supplemental correction dose. The previous endo I recently went to if you recall I was her first patient she was seeing on Afrezza as they were part of the OPTUM network (UHC) and although she was enthusiastic now that my coverage has changed for the better I went with the one experienced and has worked with the local reps (both prior rep that was with SNY and now with DEXCOM and the current rep that was with DEXCOM and now with MNKD) The reason I bring this up on this particular thread is because at the end of my visit I asked, so overall what are your thoughts about Afrezza? He used the specific term in the title of this thread, his response was very direct....."GAME CHANGER!!" ...he did add the biggest issue was coverage but he had the Afrezza posters both in the waiting rooms and in the room I was attended to so it showed his commitment and advocacy of the product. BTW, his waiting room was at full capacity. He is pretty high on the DEXCOM, I was his first patient that was using the Libre, he has seen many with the freestyle Pro over the last few mos. He asked why I chose the Libre over the DEXCOM since I knew the DEXCOM rep formerly from SNY....I said primarily the cost difference and then joked...well she bailed on Afrezza to which he correctly replied no SNY bailed on her
If you had the time and your old doc had the time it would be interesting to explain the protocol and share your results.Absolutely, as you have witnessed with other testimonials where they posted their graphs from CGM's it reflects the same direct correlation when dosing with Afrezza. If I have a spike from mealtime intake it "attacks" the spike and brings down to range target quickly....regarding the "old doc" they had no real protocol because I had to educate them, the current endo is just the opposite, he has experienced working with Afrezza for awhile now and actually is setting me up on a daily regimen/protocol along with a bi-weekly monitoring of how it is going...I have to email him my downloaded data from the Libre every two weeks...he's on top of his game |
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Post by dreamboatcruise on Jan 8, 2018 16:12:51 GMT -5
joeypotsandpans... would be interesting to know of your Afrezza supportive doc, what percent of patients needing to have prandial added to their treatment is he now prescribing Afrezza? Is it basically all that have insurance coverage? Is he switching some patients already on RAA to Afrezza?
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Post by sayhey24 on Jan 8, 2018 16:27:31 GMT -5
Joey - thats great news about your graphs. I always have to ask as I am in search of the first person taking afrezza properly who is not seeing amazing results and soon it will be three years of asking. I have not found them yet.
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Post by joeypotsandpans on Jan 9, 2018 15:16:50 GMT -5
joeypotsandpans ... would be interesting to know of your Afrezza supportive doc, what percent of patients needing to have prandial added to their treatment is he now prescribing Afrezza? Is it basically all that have insurance coverage? Is he switching some patients already on RAA to Afrezza? Good questions, I can ask on next visit |
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...he did add the biggest issue was coverage but he had the Afrezza posters both in the waiting rooms and in the room I was attended to so it showed his commitment and advocacy of the product. BTW, his waiting room was at full capacity. 
